FDA Inspection 910764 — Mindray DS USA, Inc.
The FDA completed an inspection of Mindray DS USA, Inc. on March 10, 2015 in Mahwah, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mahwah, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3266 | 21 CFR 820.86 | Acceptance status |